Ophthalmic knives recalled due to sterility assurance concerns
Tecfen Medical is recalling 92 units of 2.2mm Slit Knife, Angled (Model QKN2261) due to sterility assurance concerns. The devices were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or illnesses. The hazard is a sterility assurance issue on surgical instruments used in eye procedures; this represents a risk-of-harm scenario without reported adverse events, meeting the High severity criterion.
Plain-English summary
Tecfen Medical is recalling the 2.2mm Slit Knife, Angled (Model QKN2261), a manual ophthalmic surgical knife used to create precise incisions for entry into the eye. A total of 92 units are affected by this recall. The devices are designed to be sterile through gamma radiation sterilization and individually packaged in Tyvek 1059B material.
The recall addresses concerns regarding sterility assurance of these devices. Because these surgical knives are intended for direct use in eye surgery, where sterility is essential to prevent infection and complications, the company is recalling the affected units.
The recalled devices were manufactured on November 21, 2024 (Lot Number ZGY24080201-02, with an expiration date of November 20, 2027). They have been distributed worldwide, including in Connecticut and Minnesota in the United States, and in the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
Physicians and surgical facilities that have received affected units should stop using them and contact Tecfen Medical for instructions. Patients who may have received treatment with these instruments should consult their eye care provider if they have any health concerns.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-assurance
- infection-risk
Distribution
Distributed nationwide across the United States.
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